What is it and what is it used for?
ViraferonPeg is a medicine that contains the active substance peginterferon alfa-2b. It is available as a powder and solvent that are made up into a solution for injection, and as a single-use prefilled pen. These contain 50, 80, 100, 120 or 150 micrograms of peginterferon alfa-2b in 0.5 ml.
ViraferonPeg is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis-C virus) in patients aged three years and older.
In adults (aged 18 years and older), ViraferonPeg can be used in patients who have not been treated before or whose previous treatment failed. ViraferonPeg can be given in a triple therapy combination with ribavirin and boceprevir to adults with type-1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease). In other adults with hepatitis-C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), ViraferonPeg is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Dual therapy with ribavirin is also used in previously untreated children and adolescents (aged between three and 17 years) as long as their liver is still working normally.
The medicine can only be obtained with a prescription.
What are the benefits?
The Committee for Medicinal Products for Human Use (CHMP) decided that ViraferonPeg’s benefits are greater than its risks and recommended that it be given marketing authorisation.
The Committee noted that the dual combination with ribavirin was shown to be effective against long-term hepatitis-C-virus infection in adults and children. There is also a marked increase in cure rates in patients with long-term type-1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
What are main side effects?
In adults, the most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red-blood-cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss. In children and adolescents receiving ViraferonPeg in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10. For the full list of all side effects reported with ViraferonPeg, see the package leaflet.
ViraferonPeg must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients. ViraferonPeg must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central-nervous-system problems. It must not be used in patients who have had severe heart disease or an auto-immune disease (a disease caused by the body’s own defence system attacking normal tissue), or in children or adolescents who have had severe mental disorders, particularly severe depression, thoughts about committing suicide or suicide attempts. For a full list of restrictions, see the package leaflet.
Because ViraferonPeg is linked to side effects such as depression, patients must be closely monitored during treatment. ViraferonPeg is also linked to weight loss and reduced growth in children and adolescents. Doctors should take this risk into account when deciding whether to treat a patient before adulthood.
What studies have been done?
In adults, ViraferonPeg was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to ViraferonPeg alone and around a half responding to the combination of ViraferonPeg and ribavirin. The combination of ViraferonPeg with ribavirin was effective in patients with cirrhosis and in patients infected with HIV. Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with ViraferonPeg and ribavirin.
In the studies on triple therapy in patients with type-1 hepatitis C and compensated liver disease, ViraferonPeg in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of ViraferonPeg with ribavirin alone. Triple therapy led to an increase of about 30% in the number of previously early responders who were cured after six months. A 40% increase was seen among patients who had been treated before.
EMA website for ViraferonPeg. Accessed on 26/10/17. Links available in External Resources